Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT00543569
Eligibility Criteria:
Inclusion Criteria:
* Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
* Subject is a recipient of a de novo kidney transplant
* Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor
Exclusion Criteria:
* Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of \< 250 cells/µL
* Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
* Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
* History of hypertension and a terminal serum creatinine \> 1.5 mg/dL
* Cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
* History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00543569
Study Brief:
Protocol Section:
NCT00543569